Ovarian cancer
Conditions
Interventions
Administration of OTL38 and use of a fluorescent imaging system during surgery.
Sponsors
Leids Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Female patients 18 years of age and older 2. Have a primary diagnosis, or at high clinical suspicion, of primary ovarian cancer (of epithelial type), planned for primary surgical cytoreduction, interval debulking, or have recurrent ovarian cancer surgery, and: o Who are scheduled to undergo laparotomy for the debulking surgery OR o Who are scheduled to undergo laparoscopy and pre-authorized to undergo laparotomy for the debulking surgery if cancer is detected on the laparoscopy 3. A negative serum pregnancy test at Screening followed by a negative urine pregnancy test on the day of surgery or day of admission for female patients of childbearing potential 4. Female patients of childbearing potential or less than 2 years postmenopausal agree to use an acceptable form of contraception from the time of signing informed consent until 30 days after study completion 5. Ability to understand the requirements of the study, provide written informed consent for participation in the study and authorization of use and disclosure of protected health information, and agree to
Exclusion criteria
Exclusion criteria: 1. Previous exposure to OTL38 2. Known FR-negative ovarian cancer 3. Planned surgical debulking via laparoscopy or robotic surgery, with no intent of laparotomy. 4. Patients with known ovarian cancer miliary disease prior to surgery 5. Any medical condition that, in the opinion of the investigators, could potentially jeopardize the safety of the patient 6. History of anaphylactic reactions 7. History of allergy to any of the components of OTL38, including folic acid 8. Pregnancy or positive pregnancy test 9. Clinically significant abnormalities on electrocardiogram (ECG) 10.Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule 11.Impaired renal function defined as eGFR 3x the upper limit of normal (ULN) for alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), or total bilirubin. 13.Known Stage IV ovarian cancer with brain metastases 14.Received an investigational agent in another clinical trial within 30 days prior to surgery 15.Known sensitivity to fluorescent light
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Efficacy: * Proportion of patients with at least one evaluable FR+ ovarian cancer lesion confirmed by central pathology (Standard of truth) that was detected using the combination of OTL38 and fluorescent light but not under normal light or palpation. All evaluable FR+ ovarian cancer lesions that were identified prior to or after surgery, that were detected using the combination of OTL38 and fluorescent light but not under normal light or palpation, and were removed based on the evaluation under fluorescent light, will be included in the calculation of the proportion of patients with at least one FR+ ovarian cancer lesion confirmed by central pathology. The primary endpoint will be determined based on evaluable lesions as described below. * Evaluable lesions are defined as follows: lesions that do not appear on an organ or tissue that was intended for removal based on the Pre-Fluorescence Surgical Plan, regardless of the absence or presence of tumor. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Efficacy: * False Positive Rate at the patient level (FPRp) will be a major secondary efficacy endpoint and is defined as the proportion of folate positive ovarian cancer patients in whom all lesions, without regard to evaluable lesion status, detected by fluorescent light only, are histologically negative. * Sensitivity or True Positive Rate (TPR) for OTL38 in combination with fluorescent light, defined as the proportion of fluorescent light positive lesions that are histologically confirmed to be FR+ and ovarian cancer by central pathology relative to the total number of lesions confirmed to be FR+ and ovarian cancer by central pathology without regard to evaluable lesion status. From the classification table below: TP/TP+FN * False positive rate (FPR) for OTL38 in combination with fluorescent light, for the purpose of this protocol, will be calculated as 1 * the Positive Predictive Value (PPV) and is defined as the proportion of fluorescent light positive lesions removed that are histologically confirmed to be non-cancerous, or if cancerous, not FR+ and ovarian cancer, by central pathology relative to the total number of lesions removed with fluorescent light imaging without regard to evaluable lesion status. | — |
Countries
Netherlands
Outcome results
None listed